Company
United StatesMayo Clinic PET Radiochemistry Facility, Rochester, MN – FDA Inspections
Inspection records and compliance data for Mayo Clinic PET Radiochemistry Facility in Rochester, Minnesota. 5 FDA inspections on record, 1 Form 483, last inspected September 24, 2025.
Company Profile
This profile covers Mayo Clinic PET Radiochemistry Facility based in Rochester, Minnesota, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 5
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected March 15, 2012. Last inspected September 24, 2025.
Most cited issue areas
- Adequate controls (general)1 inspection
- Failure to develop written procedures1 inspection
- Interval1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 24, 2025 | VAI | Human Drugs · Drug Quality Assurance | 1283146 |
| December 4, 2015 | VAI | Human Drugs · Drug Quality Assurance | 950152 |
| August 3, 2015 | VAI | Human Drugs · Drug Quality Assurance | 937220 |
| July 11, 2014 | VAI | Human Drugs · Bioresearch Monitoring | 886802 |
| March 15, 2012 | VAI | Human Drugs · Drug Quality Assurance | 771806 |
FDA documents
Form 483s (1)
People (1)
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Company Information
Name
Mayo Clinic PET Radiochemistry Facility
FEI Number
3009119769
Address
200 1st St Sw, Rochester, Minnesota 55905, United States
Country
United States
ID: 6b2304d3-2e0e-4a40-9b2d-5a95a9a873cf